AB1666 CLUSTER ANALYSIS TO IDENTIFY PATIENT GROUPS AND ASSESS THE PRESENCE OF ADVERSE EVENTS. REAL WORLD EVIDENCE FROM THE BIOBADASAR 3.0 REGISTRY
Authors: J. A. Brigante, K. Roberts, C. Isnardi, G. Gómez, M. Haye, M. García, C. Gobbi, G. Casado, L. L. Holguín Arias, J. M. Dapeña, S. Papasidero, G. Berbotto, M. Viola, V. Saurit, I. Petkovic, A. Bertoli, M. P. Diaz, E. Catay, I. E. Exeni, B. Pons-Estel, G. Bovea Castelblanco, M. E. De La Sota, M. S. Larroude, D. A. Pereira, A. B. Granel, G. Medina, C. Pisoni, M. Sacnun, E. Velozo, N. Aste, C. Castro, E. Kerzberg, V. Savio, J. Gamba, A. Secco, G. Citera, E. Soriano, C. Graf, G. Pons-Estel, M. De la Vega
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> The clinical manifestations of patients with rheumatic diseases are highly heterogeneous. The appearance of adverse events (AEs) related to the treatments received for these diseases considerably increases the morbidity and mortality of these patients. This is why obtaining real-world data on these AEs and analyzing their causes is paramount. The BIOBADASAR registry has data from 5,676 patients over ten years of follow-up. Classifying patients in treatment with biological drugs into subgroups with different phenotypes through unsupervised grouping could provide valuable information on the characteristics associated with specific AE. <h3>Objectives</h3> Through cluster analysis, this study aimed to identify different clinical phenotypes related to Adverse events in patients treated with biological drugs. <h3>Methods</h3> Retrospective, multicenter study of patients with rheumatic diseases treated with original biological drugs, biosimilars, or original and generic targeted therapies in Argentina; follow-up from August 2010 to July 2021. Demographic and clinical data, time of initiation and completion of treatments, data on disease activity, and the AEs presented were collected. Patients were unbiasedly matched based on their clinical and phenotypic profiles using a k-means pooling method. The initiation of biological disease-modifying antirheumatic drugs (b-DMARD) was evaluated in the segregated groups to investigate each group's clinical course and differential characteristics. <h3>Results</h3> A total of 5676 patients were analyzed. Three different clusters were obtained: Cluster 1: 1041 patients. Was observed an evolution time of the disease of 30.5 years (Q1 25.8; Q3 35.6) longer than other clusters and a longer delay in starting treatment at 18.3 years (Q114.4; Q3 24) p &lt; 0.0001. Cluster 2: 2136 patients. We observed a higher frequency of patients with Systemic Lupus Erythematosus: 156 (7.3%) p&lt;0.0001 and a lower frequency of AEs 190 (8.9%) p &lt;0.0001 Cluster 3: 2499 patients. We observed a higher mean age than in the other two clusters, 57.3 (SD 8.3) p &lt; 0.001. The use of systemic corticosteroids was evenly distributed among the 3 clusters. <h3>Conclusion</h3> The unsupervised grouping of patients from the BIOBADASAR registry demonstrated the existence of clusters based on clinical and demographic characteristics. Identifying high-risk patients through a combination of these parameters may be helpful for the early identification of risk factors and their association with adverse events. Based on our hierarchical cluster analysis, we identified different patient phenotypes. Our results show that within the heterogeneity of patient characteristics, common elements provide a basis for future analyses of these variables and their relationship with certain AEs. <h3>REFERENCES:</h3> NIL. <h3>Acknowledgements:</h3> NIL. <h3>Disclosure of Interests</h3> Jorge Alejandro Brigante Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Karen Roberts Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Carolina Isnardi Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Gimena Gómez Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Maria Haye Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Mercedes García Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Carla Gobbi Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Gustavo Casado Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Laura Lucia Holguín Arias Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Joan Manuel Dapeña Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Silvia Papasidero Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Guillermo Berbotto Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Malena Viola Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Veronica Saurit Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Ingrid Petkovic Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Ana Bertoli Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Monica Patricia Diaz Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Erika Catay Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Ida Elena Exeni Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Bernardo Pons-Estel Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Gladys Bovea Castelblanco Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Mercedes Elena De La Sota Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Maria Silvia Larroude Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Dora Aida Pereira Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Amelia Beatriz Granel Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Gustavo Medina Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Cecilia Pisoni Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., MONICA SACNUN Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Edson Velozo Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Nora Aste Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Cecilia Castro Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Eduardo Kerzberg Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Veronica Savio Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., JULIETA GAMBA Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Anastasia Secco Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Gustavo Citera Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Enrique Soriano Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Cesar Graf Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Guillermo Pons-Estel Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database., Maria de la Vega Grant/research support from: BIOBADASAR has received an unrestricted Grant from Pfizer. Pfizer has not participated in or influenced the project's development, data collection, analysis, interpretation, or report writing. They do not have access to the information collected in the database.